Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 38 of 138
Medtronic Heart Valves Division
Class II Ongoing
CoreValve Evolut PRO Delivery Catheter System, REF: ENVPRO-14; ENVPRO-16;
Reason: Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
Z-2042-2021 July 14, 2021 Santa Ana, CA
Spes Medica
Class II Terminated
SNS Disposable Urethral Catheter Electrode, 10 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached 2 meter lead-wire with touch-proof connector, Reference Number...
Reason: The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
Z-1968-2021 July 7, 2021 Genoa, N/A
Spes Medica
Class II Terminated
SNS Disposable Urethral Catheter Electrode, 14 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached 2 meter lead-wire with touch-proof connector, Reference Number...
Reason: The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
Z-1970-2021 July 7, 2021 Genoa, N/A
Bard Access Systems Inc.
Class II Terminated
5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc Polyurethand Radiology PiCC with Microintroducer
Reason: Catheter kits contained the incorrect micro-introducers.
Z-1991-2021 July 7, 2021 Salt Lake City, UT
Bard Access Systems Inc.
Class II Terminated
5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire Unit Label: PowerPICC REF CK000340B BARD MYPICC KIT 5F French Size Dual-Lumen 70cm Guidewire
Reason: Catheter convenience kits contain the incorrect guidewire. Kits were labeled with 70cm guidewires, but contained a 50cm guidewire.
Z-1994-2021 July 7, 2021 Salt Lake City, UT
MICROVENTION INC.
Class III Terminated
VIA Microcatheter VIA 17 REF VIA-17-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature.
Reason: Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.
Z-1828-2021 June 16, 2021 Aliso Viejo, CA
MICROVENTION INC.
Class III Terminated
VIA Microcatheter VIA 21 REF VIA-21-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature.
Reason: Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.
Z-1829-2021 June 16, 2021 Aliso Viejo, CA
MICROVENTION INC.
Class III Terminated
VIA Microcatheter VIA 27 REF VIA-27-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature.
Reason: Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.
Z-1830-2021 June 16, 2021 Aliso Viejo, CA
MARVAO MEDICAL DEVICES LTD.
Class II Ongoing
NexSite HD, Hemodialysis Symmetric Tip Catheter for long term use
Reason: The action is to ensure consistency between the Directions for Use (DFU) in the field and the DFU on the website.
Z-1699-2021 June 9, 2021 Galway
Bard Access Systems Inc.
Class II Terminated
REF 7617405J, Groshong NXT ClearVue Catheter, Basic kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741200592 - Product Usage: is designed for use when central venous catheterization is prescribed.
Reason: Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot ...
Z-1653-2021 May 26, 2021 Salt Lake City, UT
Bard Access Systems Inc.
Class II Terminated
REF 7812400, Replacement Connector For 4F Groshong NXT clearVue PICC with Extension Leg, Rx Only, Sterile EO, CE 2797, UDI: (01)10801741075268 - Product Usage: is designed for use when central venous ...
Reason: Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot ...
Z-1658-2021 May 26, 2021 Salt Lake City, UT
Bard Access Systems Inc.
Class II Terminated
REF 9617408, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741036009 - Product Usage: is designed for use when central v...
Reason: Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot ...
Z-1661-2021 May 26, 2021 Salt Lake City, UT
Bard Access Systems Inc.
Class II Terminated
REF 69655405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741147521 - Product Usage: is designed for use when central...
Reason: Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot ...
Z-1664-2021 May 26, 2021 Salt Lake City, UT
Bard Access Systems Inc.
Class II Terminated
REF 9655405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741036023 - Product Usage: is designed for use when central ...
Reason: Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot ...
Z-1663-2021 May 26, 2021 Salt Lake City, UT
Bard Access Systems Inc.
Class II Terminated
REF 7617407, Groshong NXT ClearVue Catheter, Full Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035248 - Product Usage: is designed for use when central venous catheterization is prescribed.
Reason: Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot ...
Z-1669-2021 May 26, 2021 Salt Lake City, UT
Bard Access Systems Inc.
Class II Terminated
REF 7655405, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035279 - Product Usage: is designed for use when central venous catheterization is prescribed.
Reason: Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot ...
Z-1656-2021 May 26, 2021 Salt Lake City, UT
Bard Access Systems Inc.
Class II Terminated
REF 91660417, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet Tip, Basic Kit, 4F, Single-Lumen, TPS, CE 2797, UDI: (01)10801741107822 - Product Usage: is designed ...
Reason: Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot ...
Z-1665-2021 May 26, 2021 Salt Lake City, UT
Bard Access Systems Inc.
Class II Terminated
REF 7655405J, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741200615 - Product Usage: is designed for use when central venous catheterization is prescribed.
Reason: Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot ...
Z-1657-2021 May 26, 2021 Salt Lake City, UT
Bard Access Systems Inc.
Class II Terminated
REF 7617405, Groshong NXT ClearVue Catheter Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741086998 - Product Usage: is designed for use when central venous catheterization is prescribed.
Reason: Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot ...
Z-1668-2021 May 26, 2021 Salt Lake City, UT
Bard Access Systems Inc.
Class II Terminated
REF 7617400, Groshong NXT ClearVue Catheter, intermediate kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741045094 - Product Usage: is designed for use when central venous catheterization is prescribed.
Reason: Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot ...
Z-1652-2021 May 26, 2021 Salt Lake City, UT
Bard Access Systems Inc.
Class II Terminated
REF 7617408D, Groshong NXT ClearVue Catheter, Maximal Barrier Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035262 - Product Usage: is designed for use when central venous catheterization is prescrib...
Reason: Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot ...
Z-1655-2021 May 26, 2021 Salt Lake City, UT
Bard Access Systems Inc.
Class II Terminated
REF CK000516, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet, Full Kit, 4F, Single-Lumen, TPS, CE 2797, UDI: (01)10801741107891 - Product Usage: is designed for u...
Reason: Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot ...
Z-1667-2021 May 26, 2021 Salt Lake City, UT
Bard Access Systems Inc.
Class II Terminated
REF 9617407, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741035996 - Product Usage: is designed for use when central v...
Reason: Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot ...
Z-1660-2021 May 26, 2021 Salt Lake City, UT
Bard Access Systems Inc.
Class II Terminated
REF 9617408D, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Maximal Barrier Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741036016 - Product Usage: is designed for use wh...
Reason: Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot ...
Z-1662-2021 May 26, 2021 Salt Lake City, UT
Bard Access Systems Inc.
Class II Terminated
REF CK000379, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, TLS, CE 2797, UDI: (01)10801741102704 - Product Usage: is designed for use when...
Reason: Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot ...
Z-1666-2021 May 26, 2021 Salt Lake City, UT